Durex Air Large Condom

GUDID 10302340876466

Condom

RB Health (us) LLC

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• Primary Device ID: 10302340876466
• NIH Device Record Key: 3540965b-61ee-4c7e-823f-f58821fc87f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durex Air Large Condom
• Version Model Number: Condom
• Company DUNS: 081049410
• Company Name: RB Health (us) LLC
• Device Count: 36
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 * Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 * Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 * Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 * Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 * Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 * Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 * Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 * Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 * Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 * Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 * Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 * Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 * Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 * Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00302340876469 [Primary]
GS1	10302340876466 [Package]; Contains: 00302340876469; Package: Carton [3 Units]; In Commercial Distribution
GS1	20302340876463 [Package]; Package: Case [6 Units]; In Commercial Distribution
GS1	40302340876467 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200672

FDA Product Code

• HIS: Condom

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-04
• Device Publish Date: 2023-03-27

On-Brand Devices [Durex Air Large Condom]

• 40302340876498: Condom
• 10302340876480: Condom
• 10302340876473: Condom
• 10302340876466: Condom